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Food and Drug Administration, HHS § 210.

(b) of this section shall provide those titioner may direct that the Medica-
Medication Guides, or the means to tion Guide not be provided to the par-
produce Medication Guides, to each au- ticular patient. However, the author-
thorized dispenser to whom it ships a ized dispenser of a prescription drug
container of drug product. product subject to this part shall pro-
(d) The label of each container or vide a Medication Guide to any patient
package, where the container label is who requests information when the
too small, of drug product for which a drug product is dispensed regardless of
Medication Guide is required under any such direction by the licensed
this part shall instruct the authorized practitioner.
dispenser to provide a Medication
Guide to each patient to whom the PART 210—CURRENT GOOD MAN-
drug product is dispensed, and shall UFACTURING PRACTICE IN MAN-
state how the Medication Guide is pro- UFACTURING, PROCESSING,
vided. These statements shall appear PACKING, OR HOLDING OF
on the label in a prominent and con-
spicuous manner.
DRUGS; GENERAL
(e) Each authorized dispenser of a
Sec.
prescription drug product for which a 210.1 Status of current good manufacturing
Medication Guide is required under practice regulations.
this part shall, when the product is dis- 210.2 Applicability of current good manu-
pensed to a patient (or to a patient’s facturing practice regulations.
agent), provide a Medication Guide di- 210.3 Definitions.
rectly to each patient (or to the pa- AUTHORITY: 21 U.S.C. 321, 351, 352, 355, 360b,
tient’s agent) unless an exemption ap- 371, 374.
plies under § 208.26. SOURCE: 43 FR 45076, Sept, 29, 1978, unless
(f) An authorized dispenser or whole- otherwise noted.
saler is not subject to section 510 of the
Federal Food, Drug, and Cosmetic Act, § 210.1 Status of current good manu-
which requires the registration of pro- facturing practice regulations.
ducers of drugs and the listing of drugs (a) The regulations set forth in this
in commercial distribution, solely be- part and in parts 211 through 226 of this
cause of an act performed by the au- chapter contain the minimum current
thorized dispenser or wholesaler under good manufacturing practice for meth-
this part. ods to be used in, and the facilities or
controls to be used for, the manufac-
§ 208.26 Exemptions and deferrals. ture, processing, packing, or holding of
(a) FDA on its own initiative, or in a drug to assure that such drug meets
response to a written request from an the requirements of the act as to safe-
applicant, may exempt or defer any ty, and has the identity and strength
Medication Guide content or format re- and meets the quality and purity char-
quirement, except those requirements acteristics that it purports or is rep-
in § 208.20 (a)(2) and (a)(6), on the basis resented to possess.
that the requirement is inapplicable, (b) The failure to comply with any
unnecessary, or contrary to patients’ regulation set forth in this part and in
best interests. Requests from appli- parts 211 through 226 of this chapter in
cants should be submitted to the direc- the manufacture, processing, packing,
tor of the FDA division responsible for or holding of a drug shall render such
reviewing the marketing application drug to be adulterated under section
for the drug product, or for a biological 501(a)(2)(B) of the act and such drug, as
product, to the application division in well as the person who is responsible
the office with product responsibility. for the failure to comply, shall be sub-
(b) If the licensed practitioner who ject to regulatory action.
prescribes a drug product subject to
this part determines that it is not in a § 210.2 Applicability of current good
particular patient’s best interest to re- manufacturing practice regulations.
ceive a Medication Guide because of (a) The regulations in this part and
significant concerns about the effect of in parts 211 through 226 of this chapter
a Medication Guide, the licensed prac- as they may pertain to a drug and in

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